BioSpace News Archive

Drug Development

Puma Biotechnology Receives Results of CHMP Formal Decision for Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

Puma Biotechnology announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion, recommending the refusal of the Marketing Authorisation Application for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.

February 23, 2018
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7 min read
Pharm Country

R5 – Maximum Automation for Perfect Restorations

VHF Camfacture AG is introducing a highly automated milling and grinding machine for wet and dry machining that processes every material commonly used in the field of dental technology.

February 23, 2018
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4 min read
Pharm Country

LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion in Platinum-Sensitive Relapsed Ovarian Cancer

AstraZeneca and Merck’s New LYNPARZA Tablet Formulation Recommended for Maintenance Therapy Regardless of BRCA Status

February 23, 2018
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16 min read
Vascular Graft Solutions: External Stenting of Vein Grafts is Associated With High Early Patency Rates

Interim report from the post-marketing randomized VEST III trial

February 23, 2018
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3 min read
Drug Development

Amgen Receives Positive Opinion Expanding Use Of XGEVA® (denosumab) To Cover Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma In Europe

Application Based on Data From Largest International Multiple Myeloma Trial for the Prevention of Skeletal-Related Events Ever Conducted

February 23, 2018
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23 min read
Drug Development

Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 2 Clinical Trial Evaluating Defibrotide for the Prevention of Acute Graft-versus-Host Disease

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the first patient has been enrolled in a Phase 2 clinical trial evaluating the efficacy and safety of defibrotide for the prevention of acute Graft-versus-Host-Disease (aGvHD) in adult and pediatric patients after allogeneic hematopoietic stem cell transplant (HSCT).

February 23, 2018
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9 min read
FDA

Kazia Receives FDA Orphan Designation for GDC-0084

Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) is pleased to announce that the FDA has granted Orphan Drug Designation (ODD) to GDC-0084, for the treatment of glioblastoma multiforme.

February 23, 2018
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3 min read
Pharm Country

Wipro and Amrita Vishwa Vidyapeetham Jointly Win the Aegis Graham Bell Award 2017 for Innovation in ‘mHealth’

Recognized for their joint initiative - ‘Redefining primary comfort using mHealth’ at the eighth edition of the Aegis Graham Bell Awards

February 23, 2018
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5 min read